The purpose of any analytical method development, including dissolution testing, is to have a method that would describe the unknown property of the material it tests. The foremost requirement for method development practices is that one must have reference material, or a product, of the known value of the parameter or dissolution result. A method will be considered developed when this method provides the value of the reference product’s parameter (dissolution results) accurately with acceptable confidence (variance).
Unfortunately, in the case of drug dissolution testing, no such reference product is available with known or accepted dissolution value/result. Thus, in the true sense of the meaning of method development, it is impossible to develop a dissolution method that could be used to determine the unknown dissolution results of a test product.
On the other hand, current practices use the terminology of method development to choose apparatuses and associated experimental conditions that would reflect the expected or desired behavior of the test product. Another way of saying this is, the test product becomes its own “reference.” That is why products often come with their methodologies. Obviously, it is not the correct and valid understanding and method development approach, thus requiring reconsideration. An obvious outcome of such practices is that the developed method would not allow the comparison of drug dissolution (release) characteristics between products. In addition, one would never know the true dissolution rate (characteristics) of any product.
Therefore, in reality, current practices of method development in drug dissolution testing are neither accurate nor serving their intended purpose.